Blog
RSS FeedPosted by Michael Wonder on 09 Apr 2019
Health Canada approves new drug to treat metastatic breast cancer through international and domestic joint reviews
9 April 2019 - Canadians want improved access to the most recent and innovative treatment options for themselves and their ...
Posted by Michael Wonder on 09 Apr 2019
FDA approves new treatment for osteoporosis in post-menopausal women at high risk of fracture
9 April 2019 - The U.S. Food and Drug Administration today approved Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women ...
Posted by Michael Wonder on 09 Apr 2019
International work-sharing initiative - abemaciclib (Verzenio)
9 April 2019 - Abemaciclib (Verzenio) is the second medicine to be registered on the Australian Register of Therapeutic Goods ...
Posted by Michael Wonder on 09 Apr 2019
Minimal residual disease as a surrogate outcome for product development for multiple myeloma: comparing FDA and EMA guidances
8 April 2019 - This article discusses the need to update regulatory science to include the use of minimal residual disease ...
Posted by Michael Wonder on 09 Apr 2019
Biosimilars are a distraction
8 April 2019 - Biopharmaceutical products (also known as biologics) are among the most expensive pharmaceutical products on the market, and ...
Posted by Michael Wonder on 09 Apr 2019
PhaseBio receives FDA breakthrough therapy designation for PB2452 for the reversal of the anti-platelet activity of ticagrelor
8 April 2019 - In Phase 1 clinical trial, PB2452 provided immediate and sustained reversal of ticagrelor anti-platelet effects. ...
Posted by Michael Wonder on 09 Apr 2019
uniQure receives FDA fast track designation for AMT-130 gene therapy for the treatment of Huntington’s disease
8 April 2019 - On track to treat first patient in Phase I/II study of AMT-130 in 2H19. ...
Posted by Michael Wonder on 08 Apr 2019
Pazdur on pandemonium: calls for collaboration, competition on PD-1 drugs
8 April 2019 - Pazdur chastises PD-1/PD-L1 pharmas for losing sight of patients. ...
Posted by Michael Wonder on 08 Apr 2019
Zogenix receives refusal to file letter from U.S. FDA for Fintepla new drug application
8 April 2019 - Zogenix today announced that it received a refusal to file letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 08 Apr 2019
FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment
8 April 2019 - The U.S. FDA today approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of ...
Posted by Michael Wonder on 07 Apr 2019
Supporting greater availability of lower cost generic drugs for Canadians
4 April 2019 - Canadians want improved access to a wider range of safe and affordable medications. ...
Posted by Michael Wonder on 07 Apr 2019
Celgene Corporation and Acceleron Pharma announce submission of luspatercept biologics license application to U.S. FDA
5 April 2019 - Submission includes both myelodysplastic syndromes and beta-thalassemia indications. ...
Posted by Michael Wonder on 07 Apr 2019
Gilead submits supplemental new drug application to U.S. FDA for once daily Descovy for HIV pre-exposure prophylaxis
5 April 2019 - Filing supported by data demonstrating non-inferiority compared to Truvada coupled with bone and renal safety advantages in ...
Posted by Michael Wonder on 07 Apr 2019
Kyowa Kirin announces FDA acceptance of istradefylline (KW-6002) new drug application resubmission in the US
4 April 2019 - Kyowa Hakko Kirin announced that the U.S. FDA has accepted for review the resubmitted new drug ...
Posted by Michael Wonder on 07 Apr 2019
Abeona Therapeutics receives FDA fast track designation for ABO-101 for treatment of Sanfilippo syndrome type B
4 April 2019 - Ongoing Phase 1/2 study of ABO-101 enrolling eligible patients with MPS IIIB. ...